Randomised Controlled
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PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0260457
Paolo Falco ◽  
Sarah Zaccagni

Do reminders to promote social distancing achieve the desired effects on behavior? Much of the existing literature analyses impacts on people’s intentions to comply. We run a randomised controlled trial in Denmark to test different versions of a reminder to stay home at the beginning of the crisis. Using a two-stage design, we follow up with recipients and analyse their subsequent self-reported behaviour. We find that the reminder increases ex-ante intentions to comply when it emphasises the consequences of non-compliance for the subjects themselves and their families, while it has no effect when the emphasis is on other people or the country as a whole. We also find, however, that impacts on intentions do not translate into equivalent impacts on actions. Only people in poor health react to the reminder by staying home significantly more. Our results shed light on important gaps between people’s intentions and their actions in responding to the recommendations of health authorities.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Alexandra Burton ◽  
Penny Rapaport ◽  
Marina Palomo ◽  
Kathryn Lord ◽  
Jessica Budgett ◽  

Abstract Background Most people living with dementia want to remain living in their own homes and are supported to do so by family carers. No interventions have consistently demonstrated improvements to people with dementia’s life quality, functioning, or other indices of living as well as possible with dementia. We have co-produced, with health and social care professionals and family carers of people with dementia, a new intervention (NIDUS-family). To our knowledge, NIDUS-family is the first manualised intervention that can be tailored to personal goals of people living with dementia and their families and is delivered by facilitators without clinical training. The intervention utilizes components of behavioural management, carer support, psychoeducation, communication and coping skills training, enablement, and environmental adaptations, with modules selected to address dyads’ selected goals. We will evaluate the effect of NIDUS-family and usual care on goal attainment, as measured by Goal Attainment Scaling (GAS) rated by family carers, compared to usual care alone at 12-month follow-up. We will also determine whether NIDUS-family and usual care is more cost-effective than usual care alone over 12 months. Methods A randomised, two-arm, single-masked, multi-site clinical trial involving 297 people living with dementia-family carer dyads. Dyads will be randomised 2:1 to receive the NIDUS-family intervention with usual care (n = 199) or usual care alone (n = 98). The intervention group will be offered, over 1 year, via 6–8 video call or telephone sessions (or face to face if COVID-19 restrictions allow in the recruitment period) in the initial 6 months, followed by telephone follow-ups every 1–2 months to support implementation, with a trained facilitator. Discussion Increasing the time lived at home by people living with dementia is likely to benefit lives now and in the future. Our intervention, which we adapted to include remote delivery prior to trial commencement due to the COVID-19 pandemic, aims to address barriers to living as well and as independently as possible that distress people living with dementia, exacerbate family carer(s) stress, negatively affect relationships, lead to safety risks, and frequently precipitate avoidable moves to a care home. Trial registration International Standard Randomised Controlled Trials Number ISRCTN11425138. Registered on 7 October 2019

Z.K. Jabbar‐Lopez ◽  
B. Ezzamouri ◽  
A. Briley ◽  
D. Greenblatt ◽  
N. Gurung ◽  

2021 ◽  
Vol 16 (1) ◽  
Heather A. Grimes ◽  
Helen L. McLachlan ◽  
Della A. Forster ◽  
Fiona McLardie-Hore ◽  
Kate Mortensen ◽  

Abstract Background The RUBY randomised controlled trial demonstrated the benefit of proactive telephone peer support in promoting breastfeeding continuation in a setting with high breastfeeding initiation, where typically this is difficult to achieve. This paper describes the implementation and delivery of the peer support intervention with a focus on recruitment, training, and support of peer volunteers, and includes a description of the key components of the calls. Methods Data collection occurred between December 2012 and June 2016 in Melbourne, Australia. Volunteers completed enrolment forms at the training session and recorded data related to each call in a Call Log maintained for each mother supported. Data were summarised using descriptive statistics and responses to open-ended questions analysed using content analysis. Results A total of 693 women expressed interest in the peer support role, with 246 completing training, that is, 95% of whom supported at least one mother. Each supported a mean of two mothers (range 1 to 11). Training session topics included respecting individual values, using positive language, confidence building, active listening, empathetic support, and normal baby behaviour. There were 518 periods of support where at least one call was made between a volunteer and a mother to whom she was allocated. Of the 518 periods of support, 359 Call Logs (69%) were returned. The 359 call logs recorded a total of 2398 calls between peers and mothers. Call length median duration was 12 min (range 1 to 111 min). Volunteers perceived the most valued aspects of the calls were the provsion of ‘general emotional support’ (51%) and ‘general information/discussion about breastfeeding’ (44%). During the first call, mothers raised questions about ‘nipple pain/ damage’ (24%) and 'general breastfeeding information’ (23%). At ≥12 weeks postpartum, issues raised related to ‘normal infant behaviour’ (22%), ‘feed frequency’ (16%), and ‘general breastfeeding information’ (15%). Volunteers referred women to other resources during 28% of calls, most commonly to the Australian Breastfeeding Association. Conclusions Our findings demonstrate that the RUBY trial was feasible and sustainable in terms of recruiting volunteers who were willing to participate in training and who proceeded to provide peer support. Call content was responsive to the evolving breastfeeding information needs of mothers and the provision of emotional support was perceived by volunteers to be important. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN 12612001024831.

2021 ◽  
Simone Scotti Requena ◽  
Maria Ftanou ◽  
Simon Rice ◽  
Justine Fletcher ◽  

Abstract Background Approximately one fifth of Australian males aged 16 + experience mood, anxiety or substance use disorders in a given year, and suicide by males accounts for three quarters of all suicides annually. However, males with mental health problems are less likely to seek and receive help than their female counterparts. Media campaigns with videos at their core are gaining popularity as a means of promoting help-seeking for mental health difficulties, but few studies have rigorously tested the impact of such videos. This randomised controlled trial tests the effectiveness of a short video promoting help-seeking by Australian men. Methods This study is an online randomised controlled trial (RCT). Participants will attend an online group orientation session, where they will provide consent to participate and complete a baseline questionnaire (T1). After completion of the T1 questionnaire, participants will be randomised to watch either the intervention or control video on a 1:1 basis. After randomisation, participants will be able to access their allocated video for one week. Seven days after T1, participants will again be sent links to the video and to the post-exposure questionnaire (T2). One month after T2, participants will be emailed the follow-up questionnaire (T3). The primary outcome will be change in help-seeking intentions from T1 to T2. Secondary outcomes will be changes in help-seeking intentions from T1 to T3, changes in intentions to encourage other males to seek help, self-reliance, and male depression symptoms from T1 to T2 and from T1 to T3. The cost-effectiveness of the intervention will be evaluated. Participants will also complete questions about their opinions of the video and its effects at T2 and T3. Discussion Our video-based intervention is designed to promote help-seeking for mental health difficulties among Australian men. If a lack of net harm is shown to be associated with viewing the intervention video, the video will be publicly released and could have broad impacts on individual and community attitudes towards help-seeking for mental health difficulties, and ultimately enhance men’s mental health and wellbeing. An evaluation of the effectiveness of the intervention is essential to ensure the intervention is achieving its objectives. Trial registration: anzctr.org.au: 2621001008819

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